A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Drug: Bupivacaine and Fentanyl Initial Dose; Drug: Rescue Bolus; Drug: Lidocaine

• Registration Number: NCT02510287
• Lead Sponsor: Fundación Santa Fe de Bogota

Brief Summary

The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• At term pregnancy
• Laboring patients requiring epidural analgesia

Exclusion Criteria

• American Society of Anesthesiologists physical status > or equal than 3
• allergy to local anesthesics
• Neuraxial contraindications
• Hemodynamic instability
• Systemic disease such as diabetes mellitus or hypertension
• Chronic usage of analgesics
• Disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Epidural Infusion	Rescue Bolus	1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Programmed Intermittent Epidural Bolus	Rescue Bolus	1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
Continuous Epidural Infusion	Bupivacaine and Fentanyl Initial Dose	1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Programmed Intermittent Epidural Bolus	Bupivacaine and Fentanyl Initial Dose	1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .
Continuous Epidural Infusion	Lidocaine	1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
Programmed Intermittent Epidural Bolus	Lidocaine	1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered .

Primary Outcome Measures

Name	Time	Method
Pain level in laboring women measured by the Numeric Analog Scale	one year	to compare pain level in each arm once epidural analgesia is applied until birth

Trial Locations

Locations (1)

Hospital Universitario Fundación Santa Fe; 🇨🇴 Bogota, Colombia